With the FDA finalizing what exactly constitutes the meaning of “gluten-free,” consumers (especially those with celiac disease) will now be able to reliably select gluten-free foods without having to wonder what they’re actually getting.

What does that mean for you? If you have been or will be marketing gluten-free foods, you’ll need to follow these new FDA guidelines.

The term “gluten-free” now refers to foods that are either inherently gluten-free or foods that do not contain any ingredient that is:

A gluten-containing grain (e.g. spelt wheat)

Derived from a gluten-containing grain that has not been processed to remove gluten (e.g. wheat flour)

Derived from a gluten-containing grain that has been processed to remove gluten (e.g. wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food

Help for Celiac Disease

Because celiac disease has no cure, and the only treatment is dietary, this label standardization is long overdue in the minds of many. Because sufferers of celiac disease risk extreme medical problems if they were to ingest gluten, standardized labels are going to be a huge help.

Most people with celiac disease (there are approximately 3 million in the United States) can tolerate small amounts of gluten, and the 20 ppm level is the lowest that can be consistently detected, which is why the FDA instituted this threshold.

Gluten-Free Timeline

The regulation went into effect on August 5, 2013. Manufacturers will have one year to comply, meaning all foods will be subject to regulatory action if they are not in compliance by August 5, 2014.

Anyone looking for a workaround would be better advised to put that energy into complying. For the purposes of this regulation, “gluten-free,” “free of gluten,” “without gluten” and “no gluten” will be treated the same. A label making a gluten-free claim of any sort must be in compliance.